The present invention relates to forceps which are asymmetric along the length thereof and as such can be attached to various medical instruments so as to enable positioning and/or anchoring of said instruments within the body. More particularly, the present invention relates to a forceps which is attachable to an endovaginal ultrasound transducer and which is utilizable for positioning and/or anchoring said ultrasound transducer against the cervix.
The use of manipulative instruments in the course of examination of a patient, or in the course of a surgical procedure, are well known in the art.
Various forceps and retention devices have been developed which, in one way or another, conform to the physiology of a person. Specific amongst these prior art devices are retention, seizing and holding tools and forceps conformed for particular aspects of the patient""s anatomy.
Amongst these are tenaculums which also serve as uterine cervical holders and as such are conformed or adapted for intra-vaginal use. Such cervical holders can be utilized, for example, to position endovaginal ultrasound transducers against the uterine cervix so as to enable monitoring obstetric and gynecological procedures.
For example, WO 99/03399 describes an apparatus which includes a cervical holder for holding the patient""s cervix and an attached connector for interconnecting an ultrasound transducer to the cervical holder. The apparatus described in WO 99/03399 can be used to guide and monitor, in real time, intra uterine, cervical and tubal procedures such as, for example, curettage or evacuation of the uterine cavity for diagnostic and/or therapeutic purposes, and the like.
Although this apparatus provides several advantages over similar prior art devices, which advantages significantly improve the precision with which an intra uterine, cervical and tubal procedures can be performed, several limitations are still inherent to this apparatus, which limitations, in part, arise from the configuration of the cervical holder utilized thereby.
As is shown in FIGS. 1a-b, when in use, the apparatus described in WO 99/03399, is positioned within the vagina and is attached via a cervical holder or grasper onto cervical tissue, as is shown by arrow A. As a result, the ultrasound transducer, connected thereto, contacts a tissue region adjacent to the site of attachment, as shown by arrow B.
Since the finger holding portions (arrow C) of the cervical holder are positioned such that the transducer cannot be positioned directly over the cervical holder, shifting of the transducer to the side of the cervical holder is necessary. This severely limits the accuracy with which the transducer assembly is positioned since such an assembly is oftentimes placed blindly and offline, and as such a physician relies on the cervical holder to guide the transducer to the desired position. Thus, when the cervical holder and the transducer are not in the same plane, the chances or inaccurate positioning or orientation are increased. In addition, this configuration of the finger holding portions severely limits the accessibility of these portions, since they are partially blocked by the transducer, thus severely limiting the ability of a physician to operate such a cervical holder while positioning the transducer.
There is thus a widely recognized need for, and it would be highly advantageous to have, forceps which can be used to guide and anchor in position an intrabody medical instrument such as endovaginal ultrasound transducer devoid of the above limitations.
According to one aspect of the present invention there is provided a forceps useful in intrabody or surface positioning of a medical instrument or a device, the forceps comprising (a) a first arm including a first finger holding portion, a first pivot portion and a first tissue holding portion; and (b) a second arm including a second finger holding portion, a second pivot portion and a second tissue holding portion; wherein the first pivot portion is attached to the second pivot portion so as to form a pivot point about which the first and the second arms co-rotate in a scissor-like motion from a grasping position to an open position and wise versa, whereas the first and the second finger holding portions are positioned on one side of a plane defined by a length of the first arm, the plane is perpendicular to the scissor-like motion.
According to further features of the invention, in the grasping position of the forceps, (i) the tissue holding portion of the second arm on one side of the pivot point is substantially parallel to the tissue holding portion of the first arm on the corresponding side of the pivot point; (ii) the finger holding portion of the second arm on the other side of the pivot point forms an obtuse angle with respect to the tissue holding portion of the second arm; and (iii) the finger holding portions of the first and second arms terminate in finger-receiving elements which are both located on one side of the first arm and are aligned with each other in the direction of the scissor-like motion.
According to another aspect of the present invention there is provided an apparatus for guidance and monitoring of intra-uterine, cervical and tubal procedures, the apparatus comprising an assembly, including (a) an endovaginal ultrasound transducer being adapted for insertion into a portion of a patient""s vagina so as to be positionable against a cervix of the patient; (b) a forceps including (i) a first arm including a first finger holding portion, a first pivot portion and a first tissue holding portion; and (ii) a second arm including a second finger holding portion, a second pivot portion and a second tissue holding portion; wherein the first pivot portion is attached to the second pivot portion so as to form a pivot point about which the first and the second arms co-rotate in a scissor-like motion from a grasping position to an open position and wise versa, whereas the first and the second finger holding portions are positioned on one side of a plane defined by a length of the first arm, the plane is perpendicular to the scissor-like motion; and (c) a connector for interconnecting the ultrasound transducer and the forceps, the connector being constructed so as to enable counter resisted movement of the ultrasound transducer relative to the forceps, the counter resisted movement being in a direction away from the cervix.
According to yet another aspect of the present invention there is provided a system for guidance and monitoring of a medical instrument utilized in intra-uterine, cervical and tubal procedures, the system comprising (a) an endovaginal ultrasound transducer being adapted for insertion into a portion of a patient""s vagina; (b) a forceps including (i) a first arm including a first finger holding portion, a first pivot portion and a first tissue holding portion; and (ii) a second arm including a second finger holding portion, a second pivot portion and a second tissue holding portion; wherein the first pivot portion is attached to the second pivot portion so as to form a pivot point about which the first and the second arms co-rotate in a scissor-like motion from a grasping position to an open position and wise versa, whereas the first and the second finger holding portions are positioned on one side of a plane defined by a length of the first arm, the plane is perpendicular to the scissor-like motion; (c) a connector for interconnecting the ultrasound transducer and the forceps, the connector being constructed so as to enable counter resisted movement of the ultrasound transducer relative to the forceps, the movement being in a direction away from the cervix of the patient; and (d) a device for monitoring an alignment of a medical instrument with respect to an ultrasonic beam produced by the endovaginal ultrasound transducer.
According to still further features in the described preferred embodiments the first and the second tissue holding portions are adapted for grasping a cervical tissue.
According to still further features in the described preferred embodiments the connector includes (i) a forceps portion being attachable to the forceps; and (ii) an ultrasound holder portion being attachable to the forceps portion, the ultrasound holder portion including a body and an ultrasound acceptor being for holding the ultrasound transducer, the acceptor is connected to the body in a manner so as to allow counter resisted movement of the acceptor relative to the body along a longitudinal axis of the ultrasound transducer.
According to still further features in the described preferred embodiments the ultrasound holder portion further includes a spring element interposed between the acceptor and the body such that the counter resisted movement of the acceptor relative to the body in a direction opposite to the patients cervix is counter resisted by the spring element.
According to still further features in the described preferred embodiments the ultrasound holder portion further includes an ultrasound adapter element positioned within the acceptor for firmly holding the ultrasound transducer within the acceptor.
According to still further features in the described preferred embodiments the ultrasound holder portion of the connector is constructed so as to detach from the forceps portion upon an application of a force of a predetermined magnitude to the endovaginal ultrasound transducer along a longitudinal axis thereof.
According to still further features in the described preferred embodiments the forceps includes an element attached to, or integrally formed with the first arm, the element being for engaging the forceps portion of the connector.
According to still further features in the described preferred embodiments the device includes an extension coaxially connected at a distal end of the endovaginal ultrasound transducer thereby facilitating visual alignment of the medical instrument with respect to the endovaginal ultrasound transducer and therefore also with respect to the ultrasonic beam.
According to still further features in the described preferred embodiments the device includes at least one light beam generator connected either to the connector, to the ultrasound transducer or to the forceps, the light beam generator being for generating at least one light beam substantially in a plane defined by the ultrasound beam, the at least one light beam, when impinges on the medical instrument serves for facilitating visual alignment of the medical instrument with respect to the endovaginal ultrasound transducer and therefore also with respect to the ultrasound beam.
According to still further features in the described preferred embodiments the device is an imaging device connected to the endovaginal ultrasound transducer, the imaging device being for generating an image of the medical instrument superimposable on a plane defined by the ultrasound beam, thereby facilitating alignment of the medical instrument with respect to the endovaginal ultrasound transducer and therefore also with respect to the ultrasound beam.
According to still further features in the described preferred embodiments the image is displayed on a screen.
According to still further features in the described preferred embodiments the imaging device includes a camera.
According to still further features in the described preferred embodiments the camera is sensitive to light in the visible range.
According to still further features in the described preferred embodiments the camera is an infrared camera.
According to still further features in the described preferred embodiments the imaging device includes an ultrasound generator.
According to still further features in the described preferred embodiments the medical instrument is provided with marks along at least a portion thereof, the marks are identifiable by the imaging device and are therefore usable for image recognition analysis.
According to still further features in the described preferred embodiments the device includes at least two electromagnetic field generators for generating electromagnetic fields, one of the electromagnetic field generator is connected either to the connector, to the ultrasound transducer or to the forceps, whereas the other electromagnetic field generator is connected to the medical instrument, the device further includes at least one electromagnetic field sensor of a predetermined position, such that by analyzing magnetic fields perceived by the at least one electromagnetic sensor, spatial information of the relative locations of the electromagnetic field generators and therefore of the endovaginal ultrasound transducer and the medical instrument is obtainable, thereby facilitating alignment of the medical instrument with respect to the ultrasound beam.
According to still further features in the described preferred embodiments the medical instrument is selected from the group consisting of an image transmitting device and a surgical instrument.
The present invention successfully addresses the shortcomings of the presently known configurations by providing a forceps utilizable in positioning and/or anchoring of a medical device or instrument attached thereto, such as, for example, an intra-vaginal ultrasound transducer.